Scientist I, Analytical R&D
Company: Renaissance LLC
Posted on: October 10, 2020
Renaissance LLCAll qualified applicants will receive
consideration for employment without regard to race, color, sex,
sexual orientation, gender identity, religion, national origin,
disability, veteran status, age, marital status, pregnancy, genetic
information, or other legally protected status.Overview
This position supports validation activities of analytical methods
and method transfer from R&D to QC labs for new pharmaceutical
projects. Applying a working knowledge of Method Validation
theories, practices and concepts, the incumbent works under the
direct supervision of senior R&D scientists to execute
validation activities. Ensure Standard Operating Procedures and
protocols are maintained and applied.
--- Under the supervision of the R&D Manager or a Senior
Scientist, support validation activities of analytical methods and
method transfer from R&D to QC labs as per the current SOPs,
ICH and FDA guidelines.
--- Conduct routine and non-routine laboratory analyses such as
finished product testing, stability testing, and manufacturing
in-process testing of R&D /engineering batches which require
critical levels of accuracy.
--- Use analytical techniques like HPLC/UHPLC, and GC using empower
software, Karl Fisher, UV spectrophotometer etc., that is used in
analytical development activities
--- Author standard methods of analysis.
--- Author and review analytical test methods, reports and
--- Operate all laboratory analytical instrumentation and perform
troubleshooting and calibration of laboratory equipment as
--- Perform assigned various tasks which are needed to maintain the
laboratory. Such tasks may include ordering lab supplies,
calibrating instruments, cleaning glasswares and Hazmat duties.
--- Manage time effectively to complete assignments in an expected
--- Document all experimental work neatly and correctly in a lab
notebook in accordance with Standard Operating Procedures.
--- Review lab testing results and notebooks to ensure accurate
--- Ensure proper training before performing any tests and maintain
an up to date training record related to all job functions and GXP
--- Maintain current knowledge of relevant Quality System
Regulations and other regulatory requirements related to research
and development (product development, design and safety) to ensure
compliance in all research, data collection and reporting
- Maintain quality checks on safety of the Lab, including
biohazards and ensure maintenance of the facilities according to
Good Laboratory Practices
- Compile data and interpret any out of trend/specifications
against predetermined validation criteria, and update R& D
- Effectively interact with other scientists, project managers
and colleagues from numerous functions.
Bachelor's degree in Pharmaceutical Sciences, Chemistry, or similar
3-5 years relevant experience in the pharmaceutical industry.
Keywords: Renaissance LLC, Lakewood , Scientist I, Analytical R&D, Other , Lakewood, New Jersey
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